Identity
- Trade Name
- EXACTAMIX FDA UDI
- Generic Name
- Medicine bottle cap FDA UDI
- Device Name
- Tamper Resistant Add-Port Cap FDA UDI
- Model / Reference
- H9384858 FDA UDI
- Description
- Tamper Resistant Add-Port Cap FDA UDI
Identifiers
- Catalog Number
- H9384858 FDA UDI
- Primary DI / UDI-DI
- 05413765477317 FDA UDI
- FDA Product Code
- KYX FDA UDI
- GMDN Term
- Medicine bottle cap FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medicine bottle cap
Exactamix by Baxter Healthcare Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA UDI e0cd6fdd-72d6-41d0-b7f6-f56ef56a4060 35 fields · synced Jun 7, 2026